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    Liability in ob/gyn ultrasound

    Adhering to best practices for ultrasound can help reduce the chances of a lawsuit related to use of the technology.

     

    Errors leading to litigation

    Several types of errors are commonly found in liability claims against physicians: perception errors, interpretation errors, failure to suggest the next appropriate procedure, and failure to communicate critical findings to the referring physician.Case examples will illustrate such errors.

    Perception errors

    A perception error occurs when an abnormality is seen in retrospect, but was missed when interpreting the original study. A common example is a fetal anomaly that is present on the imaging study, but was not identified by the interpreting physician. A typical claim is that of wrongful birth, when the patient claims she would have terminated the pregnancy if she had known of the abnormalities.9,10 In such cases, experts establish whether it is below the standard of care for the physician not to have seen the abnormality.11 Such errors are difficult to defend, and almost 80% of such cases are lost if they go to a jury award.11As such, suits involving missed diagnoses are often settled to avoid the risk of massive awards at jury trial. Other examples include a malignant lesion not recognized on the initial ultrasound image. The resultant delay in diagnosis is alleged to increase the stage at diagnosis, reduce subsequent curability, worsen the patient’s prognosis, and, thus, shorten the patient’s life expectancy.

    Interpretation errors

    An interpretation error occurs when the abnormality is perceived but is incorrectly described. Two such instances include a malignant lesion called benign, or a normal variant called abnormal. An example of the former would be an ovarian mass, interpreted to be a dermoid but that is, in fact, a mucinous adenocarcinoma. An example of a normal variant called abnormal would be when a hemorrhagic corpus luteum is called a malignant lesion, resulting in extensive surgery that was unnecessary.

    The best defense in these cases is an appropriate differential diagnosis, preferably including the correct diagnosis, with appropriate follow-up recommendations, including additional imaging or other diagnostic options, such as endometrial biopsy or obtaining tumor markers. When such recommendations are present, these cases are much more defensible, with almost 75% won when proceeding to trial.12

    An increasingly frequent area of  litigation occurs when an intrauterine pregnancy is erroneously called an ectopic pregnancy, with subsequent treatment with methotrexate.13 Methotrexate is associated with an increased risk of pregnancy loss and, in the event of ongoing pregnancy, an increased risk of fetal anomalies.14 When the initial ultrasound fails to identify either an ectopic pregnancy or an intrauterine pregnancy, the classification should be pregnancy of unknown location (PUL).15 Recommended follow-up includes serial hCG levels and repeat ultrasound when appropriate. With abnormally rising hCG levels, an ectopic pregnancy can be suspected but not diagnosed.16 Caution should be exercised when diagnosing the absence of an intrauterine pregnancy with increasing hCG, given discriminatory levels. Current literature indicates that until the hCG level is above 2500 to 3500 mIU/mL, absence of an intrauterine gestational sac cannot be assured.17,18 Additional caution is warranted in multiple gestations because an intrauterine gestational sac may not be seen with relatively high hCG levels. Some of the most significant judgments have occurred in such cases.

    Failing to suggest the next appropriate procedure

    A prudent sonologist will suggest the next appropriate study or procedure based upon current findings and clinical presentation. For example, in the event of a significant discrepancy between size and dates, adjustment of the due date should be recommended, with follow-up confirmation with future ultrasound studies. When ectopic pregnancy is suspected and the diagnostic findings are equivocal, interpreting sonologists often recommend serial hCG levels, with a repeat ultrasound, as clinically indicated. Similarly, when ultrasound is used to screen patients with postmenopausal bleeding, an endometrial thickness > 4 mm should prompt a recommendation for further evaluation including sonohysterography, hysteroscopy, or endometrial biopsy.19

    Have you read: Using ultrasound to recognize fetal anomalies: Part 2

    Communication errors

    Sonologists who perform or interpret ultrasounds on referral are obligated to communicate significant findings to their referring physicians. Although the final written report is considered the definitive means of communicating the results of an imaging study or procedure, direct or personal communication must occur in certain situations.20For example, the finding of a significant fetal anomaly should be communicated directly to the referring physician and that communication should be documented in the final report. Failure to do so subjects the interpreting physician to a claim of wrongful birth, based on failure to communicate such findings in a timely and clinically appropriate manner.Another example is when a pregnancy due date should be changed. Cases exist in which liability was found when a patient is electively delivered prematurely, e.g. a repeat cesarean birth, and the recommendation for adjusting the due date was not clear in the final report, nor communicated to the referring physician.

    Similar liability occurs when a patient is found to have an ectopic pregnancy, which is not communicated to the referring physician in a timely manner. Such delays can lead to emergency surgery, loss of a fallopian tube, or worse, even patient death.

    Not performing an ultrasound

    In obstetrical ultrasound, there are specific indications for performing a specialized “7681" ultrasound examination.21 Not recognizing these indications and not referring to patient for a more advanced study places the practitioner at greater liability risk, particularly if a potentially diagnosable condition or abnormality could have been detected. Thus, it is critical that a provIder identify specific risk factors and promptly refer a patient to reduce his or her liability risk.

    In gynecology, failure to perform appropriate studies when patients are symptomatic exposes the physician to increased liability. For example, a menopausal patient with complaints of abdominal bloating and early satiety that occur > 13 times per month for < 1 year has symptoms concerning for ovarian cancer.22 In such cases, obtaining an ultrasound or referring the patient for one is critical. If the patient is subsequently diagnosed with ovarian cancer, failure to perform a timely ultrasound or imaging study would create significant liability risk. 

    Determining the malignant potential of an adnexal mass and need for referral to a gynecologic oncologist is crucial in patient care. A recent international consensus panel recommended that, “it is appropriate to consider referral to an expert gynecologic sonologist when faced with a challenging or indeterminate adnexal mass.”23 Failure to refer a patient for such studies would increase a physician’s risk exposure.

    NEXT: Reporting and image storage requirements

    James M. Shwayder, MD, JD
    Dr. Shwayder is Professor and Chairman, Department of Obstetrics and Gynecology, University of Mississippi Medical Center, Jackson.

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